FDA approves "12 month" indication for Evolence

This week, the FDA approved a labelling change for the collagen-based filler Evolence, permitting what is known as a "12 month indication". In simple terms, this means the FDA was satisfied that the product has a significant effect on correcting moderate to deep facial wrinkles or nasolabial folds for 12 months. The original label indication was for six-month duration.

Evolence is the first collagen-based filler to get this "12 month indication", and you can bet that it will be featured extensively in future marketing.

What is not yet clear to me, however, is whether Evolence really performs significantly better than some of the other available filler agents (which currently have the older "6 month" label from the FDA) at 12 months after injection. There is data, for example, that Restylane also has significantly lasting effects well beyond their 6 month label.

I expect Allergan and Medicis (makers of Juvederm and Restylane respectively) will be submitting their data to the FDA, hoping for a similar 12-month approval, if only for competitive marketing purposes.

Q-Med announces Restylane with lidocaine

This week, Q-Med, the Swedish pharmceutical company that is the home to Restylane and Perlane, announced Restylane® Lidocaine and Restylane Perlane™ Lidocaine as the latest additions to their Restylane family of dermal fillers. These products have the familiar Restylane and Perlane hyaluronic gel fillers, together with a small amount (0.3 %) of lidocaine, a commonly used local anesthetic, to help minimize the discomfort of the procedure.

According to the studies, the fill effect of the products is unchanged, but 90% of the patients tested said the new products made the treatments more comfortable than the standard formulation.

This allows the company to catch up with Allergan's Juvederm Ultra with Lidocaine product, which has been available in Canada and Europe for several months.

Availability of these products in the USA has not been announced. Hopefully, we'll see these later in 2009. It should be a pretty straightforward approval path with the FDA.

Here in the USA, Prevelle Silk has the combination of lidocaine and HA gel filler - but it is a much less concentrated product than either Restylane or Juvederm. I don't use Prevelle Silk often, as I don't find it is as long lasting around the mouth or smile lines.

Special offers on injectables

Good news for those patients who are fans of Juvederm, Restylane, Evolence and Botox: the manufacturers seem to be trying to out-do each other with special offers, rebates and coupons. That means savings for you.

Here's some of the current special offers:

Botox cosmetic
- Schedule your initial botox treatment before February 28, 2009 and receive a $50 rebate coupon from Allergan. Make your follow-up treatment between May 1 and July 1, 2009 and receive a second $50 rebate.


Juvederm Ultra and Juvederm Ultra Plus injectable gel
- Schedule your Juvederm treatment before February 28, 2009, and receive a $100 rebate coupon from Allergan with your second syringe of Juvederm.


Evolence collagen dermal filler
- Schedule your Evolence treatment before December 31, 2009 and receive a $50 rebate coupon for each syringe used, up to $150.


Restylane and Perlane injectable gel
- Schedule your Restylane or Perlane treatments before February 28, 2009, and get the "buy-one, get the second half-off" special.

It seems like the time to get those wrinkles treated, doesn't it!

Hello, Evolence!

Here's a new twist on an "old friend" - collagen is back, in a new & improved way. Known as Evolence - and don't ask me how they come up with these names - it's an FDA-approved filler with a good track record for wrinkle correction after being on the market several years in Europe. It's now available in the USA.

Compared to the old collagen products (Zyderm & Zyplast), Evolence offers several advantages:

1) no need for a skin test prior to treatment to check for sensitivities or allergies, which happened in about 1% of people with the old product;

2) much longer-lasting correction. European studies show a duration of about 12 months; and

3) minimal bruising from the injection.

Overall, it looks promising, and we're now going to offer it in my practice, adding another option to the many other FDA-approved fillers we have.

What will be really interesting is a head-to-head comparison study comparing Evolence to some of the better hyaluronic gel fillers. This study is underway. "Which filler will reign supreme?"...we'll have to wait and see!

The non-surgical rhinoplasty

With the advances in the world of injectable fillers, a concept known as the non-surgical rhinoplasty is beginning to become popular. Initially performed to disguise minor contour problems after a standard rhinoplasty, this technique uses Restylane or Juvederm to fill in divots or build up contours selected areas of the nose. When this is carefully done, it can sometimes save the patient from having to undergo a difficult secondary rhinoplasty procedure.

In addition, adding a small dose of Botox to reduce the activity of the small depressor septi nasi muscle can reduce the "plunging tip" effect that we sometimes see when people smile.

I've recently seen some pretty interesting results published by a group of cosmetic dermatologists, where they disguised a prominent nasal hump by building up the parts of the nasal profile immediately adjacent to the bump with fillers. While I applaud their skill with fillers, in my opinion, it makes more sense to actually perform a rhinoplasty in these cases, as reducing a prominent nasal hump surgically usually works out pretty well.